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临床试验/CTRI/2024/10/075151
CTRI/2024/10/075151招募中不适用

The impact of fixed orthodontic appliances on the oral microbiome in adolescent and adult patients using next generation sequencing (NGS) : A longitudinal comparative study.

Manav Rachna Dental College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
• A comparative analysis of oral microbiome between adolescents and adults will identify specific bacterial taxonomy responsible for gingivitis

研究概览

简要总结

Summary

Aim: To evaluate and compare oral microbiome during fixed orthodontic therapy in young and adult patients and to correlate with the clinical parameters.

Objective: To evaluate oral microbiome during fixed orthodontic therapy in adolescent patients at three different observation times

**Methodology:**Study sample collection will be started afterethical clearance. For the biological sample collection. Supragingival plaque will be isolated using cotton and airdried. Supragingival plaque will be collected using a periodontal probe, and after collection, plaque will be dropped in an Eppendorf tube containing ionized molecular water and shaken until the plaque dislodged from the tip and into the tube. A sample will be collected at time intervals- before the start of treatment (T1), During the treatment (T2), and completion of treatment (T3)

Outcomes- A comparative analysis of oral microbiome between adolescent and adults may identify specific bacterial taxonomy responsible for periodontitis, gingivitis and white spot, thus aid in formulation of a targeted approach.

研究设计

研究类型
Interventional

入排标准

年龄范围
12.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • All Class I crowding cases require maxillary first premolar extraction.

排除标准

  • • Patients with relapsed malocclusion or have undergone any previous orthodontic treatment.
  • • Patients affected by any systemic disease or smoking habits.
  • • Patients with systematic disorders and medical contraindications.
  • • Patients with already established gingivitis.

结局指标

主要结局

• A comparative analysis of oral microbiome between adolescents and adults will identify specific bacterial taxonomy responsible for gingivitis

时间窗: • T0- Baseline | T1- 6 months | T2- 2 years

次要结局

  • • The study will also establish the change in the complete microbial array during the orthodontic treatment in adolescents and adults(before the start of treatment (T1), During the treatment (T2), and completion of treatment (T3))

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

GARIMA ARORA

Manav Rachna Dental College

研究点 (1)

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